The present invention relates to a novel heat-stable form of N-methyl-N-[(1S)-1-phenyl-2-((3S)-3-hydroxypyrrolidin-1-yl)ethyl]-2,2-diph enylacetamide and to a process for the preparation and isolation of this compound in this novel form and to use for the production of medicaments which contain this compound and/or one of its physiologically acceptable salts.
Compounds of this structural formula and also the above-mentioned compound and suitable processes for their preparation are described in the Offenlegungsschrift DE 42 15 213 A1.
It has been found that the compound N-methyl-N-[(1S)-1-phenyl-2-((3S)-3-hydroxypyrrolidin-1-yl)ethyl]-2,2-diph enylacetamide, which is already known from Patent Application DE 42 15 213 A1, is a pharmaceutically particularly active compound which is very particularly suitable as a medicament for the treatment of inflammatory bowel disorders. In particular, this compound can be employed and is effective in this indication, as it simultaneously alleviates the pain associated with this disorder and in the acute case of an intestinal occlusion threatening or produced by the inflammatory bowel disorder again normalizes the motility of the intestine or sets it in motion again without causing noticeable side effects.
Attempts to prepare this compound according to the process known from DE 42 15 213 A1 have shown that this compound is obtained in various forms.
Thus, it was desirable to make available N-methyl-N-[(1S)-1-phenyl-2-((3S)-3-hydroxypyrrolidin-1-yl)ethyl]-2,2-diph enylacetamide in heat-stable form and to provide a process for the preparation of this compound, by means of which a heat-stable product is obtained which is stable on storage and suitable for the production of pharmaceutical formulations.